UK MHRA Guidance: Finding Product Information About Medicines

Access to accurate, up-to-date information about medicines is important for healthcare professionals, patients, and anyone seeking to understand how a medicine should be used safely. Product information provides details about the use of medicines, their properties, and the scientific basis for marketing authorisations.

The Medicines and Healthcare products Regulatory Agency (MHRA) has updated its guidance, Find product information about medicines, to explain how users can access key information about medicines through the MHRA Products service. The service provides access to Summary of Product Characteristics (SPCs), Patient Information Leaflets (PILs), Public Assessment Reports (PARs), and information on medicines subject to additional monitoring.

Finding Medicine Product Information

Healthcare professionals and members of the public can use the MHRA Products service to search for medicines and access different types of product information.

The service allows users to find the leaflet supplied with a medicine, information describing the medicinal product and how it should be used, and scientific reports relating to marketing authorisations.

The information is available through the MHRA Products service, which provides product information according to the medicine's licensing history.

Summary of Product Characteristics

A Summary of Product Characteristics (SPC) describes the properties of a medicinal product and the conditions attached to its use.

The SPC explains how a medicine should be used and prescribed and is intended for healthcare professionals, including doctors, nurses, and pharmacists.

For regulatory and clinical professionals, the SPC provides the product information used to understand the authorised conditions and appropriate use of a medicine.

The MHRA Products service provides the most up-to-date information for a medicine according to its licence history.

Patient Information Leaflets

Every medicine pack includes a Patient Information Leaflet (PIL), which provides information on how the medicine should be used safely.

PILs are based on the information contained in the SPC and provide medicine-related information for patients.

The MHRA Products service maintains product information that may change during the lifecycle of a medicine. PILs can be updated several times during a product's lifecycle, meaning that the leaflet supplied with a medicine may be different from an earlier version available on the website.

The service holds information for medicines licensed at a national UK level. For some medicines licensed by the European Medicines Agency, product information is available through the EMA website.

Public Assessment Reports

A Public Assessment Report (PAR) provides scientific information about the assessment of a medicine's marketing authorisation.

MHRA publishes PARs for new marketing authorisations granted after 30 October 2005. The service also publishes PARs for marketing authorisation applications that were refused after 1 April 2019.

PARs are published and edited in accordance with the relevant requirements, and provide access to scientific assessment information associated with marketing authorisations.

For medicines licensed at a European level, PARs may be prepared by the European Medicines Agency or the responsible authority of another EU member state, with the relevant reports available through those organisations.

Changes to Public Assessment Reports

The MHRA Products service also provides information about certain changes to marketing authorisations.

Subsequent non-safety changes, or variations, that are of clinical significance for a marketing authorisation are provided at the end of each PAR as separate annexes.

However, minor changes may not be represented in the PAR. Examples include changes to pack sizes and minor updates to product literature.

MHRA also publishes Safety Public Assessment Reports, which provide details of significant safety changes to a marketing authorisation.

Additional Monitoring of Medicines

MHRA also provides information about medicines subject to additional monitoring.

The additional monitoring list includes medicines authorised in the UK that are being monitored particularly closely by MHRA. Medicines under additional monitoring display a black inverted triangle in their package leaflet and Summary of Product Characteristics, together with a statement explaining the meaning of the symbol.

The MHRA and Commission on Human Medicines encourage reporting through the Yellow Card scheme of all suspected adverse reactions to medicines displaying the black triangle.

Typically, medicines containing a new active substance or new biologicals are subject to additional monitoring when their marketing authorisation is approved and for the following five years.

After five years, a medicine is normally removed from additional monitoring unless circumstances require it to remain under additional monitoring. Medicines can also be placed under additional monitoring later in their lifecycle, including following a major safety review.

Medicine Information Throughout the Product Lifecycle

The MHRA Products service reflects the importance of maintaining accessible medicine information throughout the product lifecycle.

Product information can change as medicines undergo regulatory and safety-related developments. The service therefore provides the most up-to-date information according to the medicine's licence history.

When a marketing authorisation has been cancelled, product information remains available on the website for one year. Marketing authorisation holders have six months to exhaust existing stocks after cancellation, with product information remaining available for an additional period for patients who may still have the medicine at home.

For Regulatory Affairs, Clinical, Pharmacovigilance, and healthcare professionals, the MHRA Products service provides a central source for accessing authorised product information, scientific assessment reports, and information relating to additional monitoring.

References

• MHRA Guidance: Find product information about medicines — updated 10 August 2026.